MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D 1.2M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2202-0007
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material #: 2202-0007 batch #: unknown two events were reported by customer that tubing disconnected from cvl and the other was a leak from a pinhole in the stretchy portion of the tubing in the pump chamber.: rcc received a complaint via email.Email(s) attached.I wanted to follow up after the huddle discussions re: tpn tubing issues.For 2west, the 2 incidents involving tpn tubing are completely different issues (tubing disconnected from cvl and the other was a leak from a pinhole in the stretchy portion of the tubing in the pump chamber), but both happened to occur on the same patient.I understand that 4east also experienced a leak in the tubing similar to the one on 2west.I would leave the decision about engaging the rep to come onsite to all of you from an overall patient safety perspective.I am not aware of the house wide issues with this tubing, and feel strongly that our 2 incidents on 2west are unrelated.Good morning, (b)(6) , seems we are having a few reported product issues with ref (b)(4).I have the product that failed but unfortunately do not have packaging or lot #s to provide.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing disconnected from cvl could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2202-0007 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: AS LVP 20D 1.2M
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19197533
• Report Number: 9616066-2024-00639
• Device Sequence Number: 7620000
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2202-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown